Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies with Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device

NCT ID: NCT02600208

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2026-12-31

Brief Summary

This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.

Detailed Description

The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.

Conditions

Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Experimental Arm

Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device

Group Type: EXPERIMENTAL

CliniMACs

Intervention Type: DEVICE

Depletion of Alpha Beta T cells in the PBSC graft

Interventions

CliniMACs

Depletion of Alpha Beta T cells in the PBSC graft

Intervention Type: DEVICE

Other Intervention Names

Alpha/Beta T-Cell Depletion

Eligibility Criteria

Inclusion Criteria

Patient:

1. Age. Patient age < 23 years. Both genders and all races eligible.

2. Disease eligibility

Leukemias/lymphomas:

• Acute myeloid leukemia, primary or secondary
• Disease status: remission or <10% bone marrow blasts
• Myelodysplasia
• Acute lymphoblastic leukemia
• Disease status: in hematologic remission
• Chronic myelogenous leukemia:
• Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
• Mixed lineage or biphenotypic acute leukemia
• Lymphoblastic lymphoma
• Disease status: remission
• Burkitt's lymphoma/leukemia:
• Disease status: in remission

Exclusion Criteria

• Patient

1. Patients who do not meet disease, organ or infectious criteria.

2. No suitable donor

• Maximum Eligible Age: 23 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Miltenyi Biotec, Inc.

INDUSTRY

Sponsor Role: collaborator

Julie-An M. Talano

OTHER

Sponsor Role: lead

Responsible Party

Julie-An M. Talano

Associate Professor - Department of Pediatrics - Division of Hematology/Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Julie-An Talano, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

BT13BTθ51

Identifier Type: -

Identifier Source: org_study_id